18 Research Operations jobs in Canada

Job Description

Job Description

Company Description

PSI is a leading Contract Research Organization with more 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees.  We focus on delivering quality and on-time services across a variety of therapeutic indications.

Job Description

• Coordinates investigator/ site feasibility and identification process, as well as study startup.
• Monitors project timelines and patient enrollment, implements respective corrective and preventive measures.
• Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region.
• Manages Monitors in the query resolution process, including Central Monitoring observations.
• Coordinates safety information flow and protocol/process deviation reporting.
• Performs clinical supplies management with vendors on a country and regional level.
• Ensures study-specific and corporate tracking systems are updated in a timely manner.
• Acts as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/ Project Manager.
• Coordinates planning of supervised monitoring visits and conducts the visits. 
• Manages the project team in site contracting and payments.
• Leads project team calls on a country level as well as provides status updates and reports to Regional Lead/ Project Manager.
• Ensures ongoing evaluation of data integrity and compliance at a country/regional level.
• Conducts site audit preparation visits, may participate in site audits, and coordinates resolution of site audit findings on a country/regional level.
• Oversees project team in CAPA development and implementation.
• Coordinates project team in process deviations review, management and reporting.
• Conducts initial training and authorization monitoring visits for Monitors and acts as a mentor for newly promoted Lead CRAs.
• Provides project-specific training and prepares training materials for the project team under supervision of a Project Manager and Regional Project Lead.
• Delivers trainings and presentations at Investigator Meetings.
• Prepares, conducts and reports site selection, initiation, routine monitoring and closeout visits.
• Ensures that subject recruitment targets and project timelines are properly defined, communicated, recorded, and met at site level.
• Ensures accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations.
• Supervises source data verification and follows up on data queries at site level in the country/region; reviews and manages study risks on a site level.
• Ensures proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on a country/region level.
• Reviews essential study documents and supervises reconciliation of study Investigator Site File (ISF) / TMF at site level and country/region level.
• Ensures data integrity and compliance at a site level.
• Supervises Site Management Associates in the flow of documents and laboratory supplies between the site and the Central/ Regional Lab/ Central Reviewer.
• Conducts project-specific training of site Investigators.
• Supports preparation of draft regulatory and ethics committee submission packages.

Qualifications

• Relevant educational background, such as MD, MPharm, RN or College/University degree in Life Sciences or an equivalent combination of education, training and experience.
• Minimum of 5 years’ site monitoring experience with participation in global clinical projects as a Lead Monitor. 
• Must have prior experience monitoring or managing sites and CRAs in the United States with knowledge of US regulatory guidelines and practices. 
• Experience with all types of monitoring visits in Phases I-III. 
• Strong experience in Oncology preferred.
• Experience in CAR-T Therapy or other types of Cell Therapy, Gene Therapy, Radiation Therapy or Radiopharmaceuticals, or Nuclear Medicine is preferred. 
• Strong experience in GI (Chron's, Ulcerative Colitis, IBS) preferred. 
• Full working proficiency in English.
• Proficiency in MS Office applications.
• Ability to plan, multitask and work in a dynamic team environment.
• Excellent Communication, collaboration, and problem-solving skills.
• Ability to travel up to 65% (depending on project needs).
• Valid driver’s license (if applicable).

Additional Information

All your information will be kept confidential according to EEO guidelines.

For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
**Role:**
CRA Level I/II
**Location:**
CAN, Toronto- Remote
**Experience Requirements:**
Previous Clinical Monitoring; on site or Remote
**(REQUIRED)**
Travel- up to 80%
**(REQUIRED)**
At Thermo Fisher Scientific, youu2019ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on u2013 now and in the future.
**Location/Division Specific Information**
Our global Clinical Operations colleagues within our PPDu00ae clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.
**Discover Impactful Work:**
Performs and coordinates different aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.
**A day in the Life:**
Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
Assess investigational product through physical inventory and records review.
Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.
Participates in investigator meetings as necessary. May help to identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.
Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
Provides trial status tracking and progress update reports to the team as required. Ensures study systems are complete, accurate and updated per agreed study conventions (e.g. Clinical Trial Management System).
Facilitates effective communication between investigative sites, the client company and internal project teams through written, oral and/or electronic contacts. Responds to company, client and applicable regulatory requirements/audits/inspections.
Maintains and completes administrative tasks such as expense reports and timesheets in a timely manner.
Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members. Contributes to other project work and initiatives for process improvement, as required.
**Keys to Success:**
**Education**
Bachelor''s degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
**Experience**
Minimal clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years) in a clinical environment where experience is gained in clinical trials, medical terminology, medical research, clinical research or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered.
Valid driver''s license where applicable.
**_In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role._**
**Knowledge, Skills, Abilities**
Basic medical/therapeutic area knowledge and understanding of medical terminology
Ability to attain and maintain a working knowledge of ICH GCPs and applicable regulations and
procedural documents
Good oral and written communication skills, with the ability to communicate effectively with medical personnel
Good interpersonal skills
Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customersu2019 underlying issues
Good organizational and time management skills
Ability to remain flexibile and adaptable in a wide range of scenarios
Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth
investigation for appropriate root cause analysis and problem solving
Ability to manage Risk Based Monitoring concepts and processes
Ability to work in a team or independently as required
Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate
software
Good English language and grammar skills
**Work Environment**
Thermo Fisher Scientific values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary for typical working hours.
Able to work in non-traditional work environments.
Able to use and learn standard office equipment and technology with proficiency.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.
This role requires independent travel up to 80%, inclusive of traveling in automobiles, airplanes, and trains.
**Benefits**
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
u00b7 Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.
u00b7 Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
u00b7 Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).
u00b7 Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
u00b7 Responds to company, client and applicable regulatory requirements/audits/inspections.
u00b7 Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
u00b7 Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.
u00b7 Contributes to other project work and initiatives for process improvement, as required.
**Du00e9tails du poste:**
**Poste :**
CRA Niveau I/II
**Lieu :**
Canada **,**
Toronto- u00e0 distance
**Expu00e9rience requise :**
Expu00e9rience antu00e9rieure en surveillance clinique ; sur place ou u00e0 distance
**(OBLIGATOIRE)**
Du00e9placements : jusquu2019u00e0 80 %
**(OBLIGATOIRE)**
Chez Thermo Fisher Scientific, vous du00e9couvrirez un travail significatif ayant un impact positif u00e0 l''u00e9chelle mondiale. Rejoignez nos collu00e8gues pour donner vie u00e0 notre mission - permettre u00e0 nos clients de rendre le monde plus sain, plus propre et plus su00fbr. Nous fournissons u00e0 nos u00e9quipes les ressources nu00e9cessaires pour atteindre leurs objectifs de carriu00e8re individuelle tout en faisant progresser la science par la recherche, le du00e9veloppement et la livraison de thu00e9rapies ru00e9volutionnaires. Avec des essais cliniques menu00e9s dans plus de 100 pays et le du00e9veloppement continu de nouveaux cadres pour la recherche clinique u00e0 travers notre portefeuille de recherche clinique PPD, notre travail couvre les services de laboratoire, d''essais cliniques numu00e9riques et du00e9centralisu00e9s. Votre du00e9termination u00e0 fournir qualitu00e9 et pru00e9cision amu00e9liorera les ru00e9sultats de santu00e9 dont du00e9pendent les personnes et les communautu00e9s - maintenant et u00e0 l''avenir.
**Informations spu00e9cifiques sur le lieu / division**
Nos collu00e8gues mondiaux des Opu00e9rations Cliniques au sein de nos services de recherche clinique PPDu00ae fournissent un support complet pour les essais cliniques, depuis le du00e9marrage de l''u00e9tude jusqu''u00e0 la surveillance et la clu00f4ture de l''u00e9tude, sur des contrats commerciaux et gouvernementaux. Ensemble, nous aidons les clients u00e0 du00e9finir et du00e9velopper des programmes cliniques, u00e0 minimiser les retards et u00e0 exu00e9cuter des u00e9tudes cliniques de haute qualitu00e9 et rentables.
**Du00e9couvrez un Travail Impactant :**
Ru00e9alise et coordonne tous les aspects du processus de surveillance clinique et de gestion de site. Effectue des visites u00e0 distance ou sur site pour u00e9valuer la conformitu00e9 aux protocoles et aux ru00e9glementations, et gu00e8re la documentation requise. Gu00e8re les procu00e9dures et les lignes directrices provenant de diffu00e9rents sponsors et / ou environnements de surveillance (c''est-u00e0-dire FSO, FSP, gouvernement, etc.). Agit en tant que spu00e9cialiste des processus de site, en s''assurant que l''essai est conduit conformu00e9ment au protocole approuvu00e9, aux lignes directrices ICH-GCP, aux ru00e9glementations applicables et aux SOP pour garantir les droits, le bien-u00eatre des sujets et la fiabilitu00e9 des donnu00e9es. Assure la pru00e9paration aux audits. Du00e9veloppe des relations collaboratives avec les sites d''investigation. Les tu00e2ches et responsabilitu00e9s du00e9taillu00e9es assignu00e9es u00e0 ce ru00f4le sont du00e9crites dans la matrice des tu00e2ches.
**Une journu00e9e type :**
Surveille les sites des investigateurs avec une approche de surveillance basu00e9e sur les risques : applique l''analyse des causes profondes (RCA), la pensu00e9e critique et les compu00e9tences en ru00e9solution de problu00e8mes pour identifier les du00e9faillances des processus du site et les actions correctives / pru00e9ventives pour assurer la conformitu00e9 du site et ru00e9duire les risques. Assure l''exactitude des donnu00e9es gru00e2ce u00e0 l''examen des SDR, SDV et CRF, selon les activitu00e9s de surveillance sur site et u00e0 distance
u00c9value le produit d''investigation par l''inventaire physique et l''examen des dossiers
Documente les observations dans des rapports et lettres en utilisant des normes d''u00e9criture commerciale approuvu00e9es et dans les du00e9lais impartis. Signale rapidement les du00e9ficiences et problu00e8mes observu00e9s u00e0 la direction clinique et suit toutes les issues jusqu''u00e0 leur ru00e9solution
Peut maintenir un contact ru00e9gulier entre les visites de surveillance avec les sites d''investigation pour confirmer que le protocole est suivi, que les problu00e8mes identifiu00e9s pru00e9cu00e9demment sont ru00e9solus et que les donnu00e9es sont enregistru00e9es en temps voulu. Effectue les tu00e2ches de surveillance conformu00e9ment au plan de surveillance approuvu00e9. Participe au processus de paiement des investigateurs. Assume une responsabilitu00e9 partagu00e9e avec les autres membres de l''u00e9quipe projet pour la ru00e9solution des problu00e8mes et des constatations. Enquu00eate et suit les constatations le cas u00e9chu00e9ant
Participe aux ru00e9unions des investigateurs selon les besoins. Peut aider u00e0 identifier les investigateurs potentiels en collaboration avec l''entreprise cliente pour assurer l''acceptabilitu00e9 des sites d''investigation qualifiu00e9s. Initie les sites d''essais cliniques selon les procu00e9dures pertinentes pour assurer la conformitu00e9 avec le protocole, les obligations ru00e9glementaires et ICH GCP, en faisant des recommandations lorsque nu00e9cessaire. Effectue la clu00f4ture de l''essai et la ru00e9cupu00e9ration des documents d''essai
S''assure que les documents essentiels requis sont complets et en place, conformu00e9ment u00e0 ICH-GCP et aux ru00e9glementations applicables. Effectue des revues de dossiers sur site selon les spu00e9cifications du projet
Fournit un suivi de l''u00e9tat de l''essai et des rapports de progression u00e0 l''u00e9quipe selon les besoins. S''assure que les systu00e8mes d''u00e9tude sont complets, exacts et mis u00e0 jour selon les conventions d''u00e9tude convenues (par ex. Systu00e8me de gestion des essais cliniques)
Facilite la communication efficace entre les sites d''investigation, l''entreprise cliente et les u00e9quipes de projet internes par contacts u00e9crits, oraux et / ou u00e9lectroniques. Ru00e9pond aux exigences / audits / inspections de l''entreprise, du client et des ru00e9glementations applicables
Maintient et complu00e8te les tu00e2ches administratives telles que les rapports de du00e9penses et les feuilles de temps en temps opportun
Contribue u00e0 l''u00e9quipe projet en aidant u00e0 la pru00e9paration des publications / outils du projet et en partageant des idu00e9es / suggestions avec les membres de l''u00e9quipe. Contribue u00e0 d''autres travaux de projet et initiatives d''amu00e9lioration des processus, selon les besoins
**Clu00e9s du succu00e8s :**
u00c9ducation
Diplu00f4me de baccalauru00e9at dans un domaine des sciences de la vie ou certification en soins infirmiers enregistru00e9e, ou u00e9quivalent, ainsi qu''une qualification acadu00e9mique / vocationnelle formelle pertinente
Expu00e9rience
Expu00e9rience minimale de surveillance clinique fournissant les connaissances, compu00e9tences et capacitu00e9s pour effectuer le travail (comparable u00e0 2 ans) dans un environnement clinique ou00f9 l''expu00e9rience est acquise dans les essais cliniques, la terminologie mu00e9dicale, la recherche mu00e9dicale, la recherche clinique ou les sciences de la santu00e9, ou expu00e9rience dans un domaine des sciences de la santu00e9 avec une formation formelle en terminologie mu00e9dicale et en anatomie
Permis de conduire valide
**_Dans certains cas, une u00e9quivalence, consistant en une combinaison de formations et / ou d''expu00e9riences directement liu00e9es, sera considu00e9ru00e9e comme suffisante pour qu''un individu ru00e9ponde aux exigences du poste._**
Connaissances, compu00e9tences, capacitu00e9s
Connaissance de base des domaines mu00e9dicaux / thu00e9rapeutiques et compru00e9hension de la terminologie mu00e9dicale
Capacitu00e9 u00e0 acquu00e9rir et maintenir une connaissance pratique des ICH GCP et des ru00e9glementations applicables ainsi que des documents procu00e9duraux
Bonnes compu00e9tences en communication orale et u00e9crite, avec la capacitu00e9 de communiquer efficacement avec le personnel mu00e9dical
Bonnes compu00e9tences interpersonnelles
Capacitu00e9 u00e0 maintenir l''attention sur le client en utilisant de bonnes compu00e9tences d''u00e9coute, une attention aux du00e9tails et la capacitu00e9 de percevoir les problu00e8mes sous-jacents des clients
Bonnes compu00e9tences en organisation et gestion du temps
Capacitu00e9 u00e0 rester flexible et adaptable dans une large gamme de scu00e9narios
Compu00e9tences du00e9veloppu00e9es en pensu00e9e critique, y compris mais sans s''y limiter : esprit critique, investigation approfondie pour une analyse appropriu00e9e des causes profondes et ru00e9solution de problu00e8mes
Capacitu00e9 u00e0 gu00e9rer les concepts et processus de surveillance basu00e9es sur les risques
Capacitu00e9 u00e0 travailler en u00e9quipe ou de maniu00e8re indu00e9pendante selon les besoins
Bonnes compu00e9tences informatiques : solide connaissance de Microsoft Office et capacitu00e9 u00e0 apprendre u00e0 utiliser les logiciels appropriu00e9s
Bonnes compu00e9tences en anglais et en grammaire
**Environnement de travail**
Thermo Fisher Scientific valorise la santu00e9 et le bien-u00eatre de ses employu00e9s. Nous encourageons et soutenons les individus u00e0 cru00e9er un environnement sain et u00e9quilibru00e9 ou00f9 ils peuvent s''u00e9panouir. Ci-dessous sont u00e9numu00e9ru00e9s l''environnement de travail et les exigences pour ce poste :
Capable de communiquer, recevoir et comprendre des informations et des idu00e9es avec des groupes diversifiu00e9s de personnes de maniu00e8re compru00e9hensible et raisonnable
Capable de travailler debout et immobile pendant les heures de travail habituelles
Capable de travailler dans des environnements de travail non traditionnels
Capable d''utiliser et d''apprendre u00e0 utiliser efficacement des u00e9quipements de bureau standard et des technologies
Capable de performer avec succu00e8s sous pression tout en priorisant et gu00e9rant plusieurs projets ou activitu00e9s
Peut u00eatre exposu00e9 u00e0 des u00e9lu00e9ments potentiellement dangereux typiquement trouvu00e9s dans les environnements de soins de santu00e9 ou de laboratoire
Ce poste nu00e9cessite des du00e9placements indu00e9pendants jusqu''u00e0 80 %, incluant les du00e9placements en voiture, en avion et en train
**Avantages**
Nous offrons une ru00e9munu00e9ration compu00e9titive, un plan de bonus incitatif annuel, des soins de santu00e9, ainsi qu''une gamme d''avantages sociaux. Thermo Fisher Scientific propose un emploi au sein d''une organisation innovante et tournu00e9e vers l''avenir, offrant d''excellentes perspectives de carriu00e8re et de du00e9veloppement. Nous promouvons une culture d''entreprise passionnante, caractu00e9risu00e9e par l''intu00e9gritu00e9, l''intensitu00e9, l''engagement et l''innovation !
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.